Regulatory Affairs Associate

Adaptive Biotechnologies is a biotechnology company focused on harnessing the adaptive immune system to transform disease diagnosis and treatment. The Regulatory Affairs Associate assists with regulatory submissions for new or modified in vitro diagnostic devices in U.S. and international markets, maintains regulatory files and documentation, and supports compliance activities and cross-functional regulatory guidance.

Responsibilities

Assists in writing and implementing process improvements for Regulatory Affairs functions

Maintains and performs regulatory document filing and retrieval in conjunction with SOPs

Compiles, coordinates, and formats materials required in submissions, license applications, technical file documentation etc

Maintains files related to FDA/global regulatory registrations, including communications with FDA/Global regulatory agencies

Coordinates and formats submissions per FDA and/or other global health authority requirements

Assists in the creation and implementation of regulatory affairs department policies and procedures to ensure that regulatory compliance is maintained or enhanced

Support operations by reviewing incoming project contracts and provide guidance for regulatory requirements for projects, as required

Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product

All other duties as assigned

Preferred

Demonstrates knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output

Knowledge of FDA and quality systems regulation (QSRs)

Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories

Adaptive is not currently sponsoring candidates requiring work authorization support for this position

FDA Guidelines

Quality Systems Regulation (QSR)

Vitro Diagnostics (IVD)

Molecular Diagnostics

PCR-Based Assays

Sequencing Technologies

CLIA Laboratories

Benefits

Equity grant

Bonus eligible

Company

Immune profiling platform for diagnosing and treating disease

Seattle, Washington, USA

http://adaptivebiotech.com/

Founded in 2009

501-1000 employees

Qualifications

Bachelor's Degree

2+ years of experience in regulatory affairs in the diagnostic or pharmaceutical industry, regulatory science or related degree or certification, or other related experience

Demonstrates knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output

Knowledge of FDA and quality systems regulation (QSRs)

Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories

Adaptive is not currently sponsoring candidates requiring work authorization support for this position

Required skills

Regulatory Affairs, FDA Guidelines, FDA Quality System Regulations (QSRs), Vitro Diagnostic (IVD) Devices, Molecular Diagnostics, PCR-Based Assays, Sequencing Technologies, CLIA Laboratories

Preferred skills

Knowledge of FDA and quality systems regulation (QSRs)

Experience

2+ years